Crinone

Crinone

progesterone

Manufacturer:

PT. Merck Tbk
Full Prescribing Info
Contents
Progesterone.
Description
Each 8% gel contains progesterone 90 mg/dose.
It also contains the following excipients: Glycerin, light liquid paraffin, hydrogenated palm oil, glyceride, carbomer 974P, sorbic acid, polycarbophil, sodium hydroxide and purified water.
Action
Pharmacology: Pharmacodynamics: Crinone's pharmacodynamic properties are the same as those of the naturally occurring progesterone with induction of a full secretory endometrium.
Pharmacokinetics: The progesterone vaginal gel is based on a polycarbophil delivery system which attaches to the vaginal mucosa and provides a prolonged release of progesterone for at least 3 days.
Toxicology: Preclinical Safety Data: In rabbits, Crinone was an eye irritant categorized as class IV (minimal effects clearing in <24 hrs), but not a dermal irritant.
A moderate vaginal irritation was found in rabbits after application of 2 mL daily of 8% gel for 5 days.
Indications/Uses
Treatment of infertility due to inadequate luteal phase; for use during in vitro fertilisation, where infertility is mainly due to tubal, idiopathic or endometriosis-linked sterility associated with normal ovulatory cycles.
Dosage/Direction for Use
Treatment of Infertility due to Inadequate Luteal Phase: 1 application daily, starting after documented ovulation or arbitrarily on the 18th-21st day of cycle. When used during in vitro fertilization, daily application of 8% gel should be continued for 1 month if there is laboratory evidence of pregnancy.
Recommended Duration of Therapy: 12 weeks.
Overdosage
Not applicable.
Contraindications
Known hypersensitivity to progesterone or to any of the excipients of Crinone. Undiagnosed uterine bleeding and porphyria.
Special Precautions
Caution is recommended for use in severe hepatic insufficiency.
Effects on the Ability to Drive or Operate Machinery: Drivers and users of machines are warned that risk of somnolence may occur.
Use in pregnancy & lactation: In case of corpus luteum deficiency, Crinone can be used during the 1st month of pregnancy. Do not use Crinone on breastfeeding mother.
Use in children and the elderly: Not applicable for use in this population.
Use In Pregnancy & Lactation
In case of corpus luteum deficiency, Crinone can be used during the 1st month of pregnancy. Do not use Crinone on breastfeeding mother.
Adverse Reactions
Rare cases of somnolence. Occasional spotting.
Drug Interactions
Crinone should not be used concurrently with other local intravaginal therapy.
Incompatibilities: No incompatibilities were found with the usual contraceptive devices.
Caution For Usage
Instructions for Use/Handling: Each applicator is applied directly from the specially designed sealed applicator into the vaginal. Remove the applicator firmly by the thick end shake down like a thermometer to ensure that the contents are at the thin end. Twist off the tablet and discard. The applicator may be inserted while in a sitting position or when lying on back with the knees bent. Gently insert the thin end of applicator well into the vagina. Press the thick end of the applicator and discard in a waste container. Crinone coats the vaginal mucosa to provide long lasting release of progesterone.
Storage
Store below 25°C.
Shelf-Life: 36 months.
ATC Classification
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Presentation/Packing
Vag gel 8% x 90 mg x 15's.
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